PROFESSIONAL SUMMARY:

• Qualified professional with 7+ years of extensive experience in the field of Business Analysis, Regulatory and Compliance Assurance and Change Control Process Management, working with the technical staff to implement management and staff's business requirements into the software application in various domains.
• Proficient in RUP, WATERFALL and AGILE Client /server architecture providing a well - balanced understanding of business relationships, business requirements and worked for technical solutions to help the team at all levels until final product release.
• Good understanding of Data Warehousing, Data Mart, ETL process, Data Mapping, Data Modeling, and Data Research.
• Expertise in Information Technology/ Data/ Process Management with emphasis on Business Systems Analysis.
• Efficient in conducting workshops and Joint Application Development (JAD) sessions, Project meetings, Reviews and walk through sessions.
• Worked with several ERP Systems including Oracle, PRMS, JDEand SAP.
• Earned good knowledge in RDBMS, Oracle, SQL, and PL/SQL along with MS SQL Administrator, SQL Enterprise manager, data analysis and reporting.
• Expertise using MS Visio, Rational Requisite Pro for modeling and capturing business requirements.
• Experience in developing project plans using MS Project and MS Share Point, identifying documents, and validating requirements and re-engineering process.
• Experienced in creating test plans, test cases, test results analysis with the testing team and reporting defect management and test status matrices.
• Experienced in providing Validation/SDLC compliance leadership and direction to business and project teams in Software Development Life Cycle (SDLC)/Computer System Validation (CSV)/ Infrastructure Qualification standards and practices.
• Knowledge of FDA 21 CFR Part 820, FDA 21 CFR Part 11 and ISO 13485, ISO 9001, ISO 20000 & ISO27001
• Organized Quality Presentations/ Quizzes (ISO-56K) to familiarize new Project Managers on the process
• Coached Project Managers/ Project Teams in identifying the Quality System, GxP, SOX Impacted Systems
• Comprehensive knowledge of the methodologies and principles of Change Control Management
• Solid knowledge of how people go through the Change Control Process (CRB Approval/ CCB Approval)
• Subject Matter Expert on SDLC/Qualification procedure/ Quality Process and able to guide IT and Business
• Experienced on cross-functional teams to validate/verify, implement, and maintain regulated (Example: GxP, SOX, Test Protocols (IQ/OQ/PQ) so forth. and non-regulated systems.
• Experienced in Systems Testing, Integration Testing, and Software Quality Standards, Training, Documentation, and implementation in a business environment.
• Excellent communication and presentation skills. Experience working with business users as well as senior management.

TECHNICAL SKILLS:

SDLC Methodologies: Agile, RUP, Waterfall, Rapid Application Development (RAD), V-Model

Requirement Management: MS Visio 2010/ 2013, MS Office, Rational Requisite Pro, Rational DOOR, MS Paint

Project Management: MS Project 2016, MS Office 2016, Lotus Notes, MS Outlook, JIRA, HP-ALM

Presentation: MS PowerPoint 2016, VISIO

Database: SQL Server, Oracle, MS Access, DB2, AS/400, PEGA

Change Management: Rational Clear Quest

Enterprise Resource Planning (ERP) software: JD Edwards, JDA, PRMS, Oracle, SAP

Version Control: Rational Clear Case, MS SharePoint 2016

Operating System: Window XP, Window Vista, Window 7

Programming Languages: C, C++, HTML, XML

Data Modeling Analysis: Rational Rose, Power Designer 16, MS Visio, TOAD data modeler

PROFESSIONAL EXPERIENCE:

Confidential

Sr Business Analyst

Responsibilities:

• Worked directly with business departments and manage a pipeline of Information Technology projects and enhancements related to Confidential Identification, and associated data management
• Developed requirements, procedures, workflows and manage various shared data elements for MDM and RA Team
• Identified and prioritized required technical workflows across the three main systems (PEGA; GIC; JDE) and system capabilities to ensure world-wide UDI requirements are met by working with technical GIS groups and the business
• Engaged in efforts to identify and act upon evolving world-wide regulations, directives and standards related to UDI data submissions.
• Translated regulations, directives and customer UDI requirements into requirements and strategic capabilities.
• Established written procedures for the Shared Data/UDI group’s activities.
• Co-Developed a roadmap of UDI related projects and initiatives for enablement of new capabilities.
• Established processes and manage various data elements within Confidential ’s systems (e.g., Pega Business Processes)
• Worked closely with the Validation Lead and Business Analyst to ensure test scripts are ready for OQ (HPALM) and PQ (Business Users)
• Participated, performed, and led related testing efforts. (ITC1, ITC2 Testing)
• Prepared Functional Design Specifications, Attachment A, and the corresponding Business Workflows
• Onboarded the new hires on behalf of the UDI Project Team for Confidential Systems (Regulated Items/ Non-Regulated Items), Confidential Project, PCRs (Process Change Requests)
• Spearheaded Dry-Run Testing to verify fulfillment of requirements, resolving any ensuing defects using JIRA
• Worked on JDE for Global/ Regional Item Creation; Exception Management Report; UP & GTIN Generations
• Led as a Subject Matter Expert on SDLC/Qualification procedure and able to guide IT and Business (RA Team)
• Prepared Qualification Plan, Protocols, Test Plans, Risk Assessments, Reports, Trace Matrix commensurate with project complexity JDE Item Master knowledge
• Worked with business representatives to ensure the test cases reflect business rules and business processes (VISIO)
• Solid experience working with validated systems (PEGA Systems), HPALM, GUDID US regulatory requirement,
• Ensured that system/application meets its requirements as outlined in system specification per process defined in the Validation Plan for the project.
• Identified and escalated, as necessary project risks and issues to the Validation Lead and/or Project Manager.

Environment: JD Edwards, PEGA Systems, JIRA, HP-ALM Quality Center, MDM

Confidential

Sr. Validation/Business Analyst; Change Control Process Specialist

Responsibilities:

• Led the internal audit team at Confidential for closed migrations (42 Migrations)
• Outlined the IT Quality Documentation across 150+ migrations to maintain regulatory and compliance
• Organized Quality Presentations/ Quizzes (ISO-56K) to familiarize new Project Managers on the process
• Coached Project Managers/ Project Teams in identifying the Quality System, GxP, SOX Impacted Systems
• Participated in defining the customized Quality Process for Confidential in adherence to SDLC Validation processes
• Oversaw the development and operation of change management methodologies and procedures
• Composed and documented validation strategies; Validation Plans, Risk Assessments, Traceability Matrices, Validation Summary Report, and other validation documents as needed.
• Spearheaded User Acceptance Testing to verify fulfillment of requirements, resolving any ensuing defects.
• Comprehensive knowledge of the methodologies and principles of change management
• Solid knowledge of how people go through the change and change management process (CRB Approval)
• In-depth knowledge of project management tools, approaches, and phases of the project lifecycle
• Monitored and evaluated organization's performance after implementing the change management process
• Knowledge of FDA 21 CFR Part 820, FDA 21 CFR Part 11 and ISO 13485, ISO 9001, ISO 20000 & ISO27001
• Led the Change Control Lifecycle Process at Confidential from Planning Phase to Close Phase
• Approved and assessed changes as a CCB Approver & Quality Review Approver on all migrations for Confidential
• Led the Decommissioning of the Servers Effort; Migration of Servers & Applications
• Coached and mentored others in quality topics and activities
• Exceeded as a subject matter expert on quality and documentation requirements for Confidential
• Demonstrated the ability to exhibit a positive, energetic approach to teamwork.
• Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
• Excellent documentation skills from building Qualification Plan to Qualification Summary Reports
• Demonstrated success working with others, learning from others, and building consensus to achieve established goals
• Subject Matter Expert on SDLC/Qualification procedure and able to guide IT and Business
• Participated on cross-functional teams to validate/verify, implement, and maintain regulated (Example: GxP, SOX, Test Protocols (IQ/OQ/PQ) so forth. and non-regulated systems.
• Led the validation/verification/qualification strategy by either working with the offshore testers to develop the test strategy or develop the strategy, then obtaining approval from the business and IT
• Participated in the delivery of system solutions by documenting SDLC/CSV/Qualification activities.
• Developed validation/qualification/migration/verification strategies for software, data, hardware, infrastructure and business processes before release into a live environment per company procedure(s).
• Executed validation/qualification/verification/migration strategies per company procedure(s).
• Cultivated and maintained contact with key customers, including IT and Business; working closely with vendors to complete required tasks
• Proactively identified and assisted in prioritizing opportunities to streamline testing and quality but still stayed compliant

Environment: Saleforce.com, Oracle, Informatica, Toad, SQL Navigator, XML, MS Visio, PRMS, Windows 7

Confidential

Business Analyst

Responsibilities:

• In-depth knowledge of UDI ( Confidential identifier) and GUDID (Global Unique Identification Database) and the FDA requirements
• Knowledge of the medical device industry, and understanding of medical device distribution processes and functions
• Identified and prioritized required technical workflows and system capabilities to ensure world-wide UDI requirements are met by working with technical groups and the business.
• Engaged in efforts to identify and act upon evolving world-wide regulations, directives and standards related to UDI data submissions.
• Performed Structural/ Unit Testing in the PRMS v8.4 including positive/ negative testing
• Assisted in defining and documenting Functional Design Specifications/ User Requirements Documents
• Created test scripts for functional testing and UAT Testing based on user requirements.
• Created other system documentation where applicable, adhering to IT Quality standards for quality assurance
• Gathered requirements, create design specifications, and develop application code for system enhancements, interfaces, and reports.
• Participated in the design and development of test plans for executing unit, integration, system or acceptance testing to ensure solution meets the business requirements.
• Excellent oral and written communications, interpersonal, negotiation, judgment, decision-making, analysis and problem-solving skills.
• Expert knowledge of MS Word, Excel, and Visio, MS Project
• Held responsible for starting RUP and UML Processes for Creation of Documentation to be used by IT Team.
• Created and tracked approvals for main audit documents like Testing Strategy, Testing Summary Report
• Executed Functional/ UAT scripts in PRMS v.84 to ensure GS1 barcodes are working as intended
• Gathered requirements and analyzed the federal legislation to update products as per the provisions of Health Care Reform system
• Used Mercury (HP) Quality Center (QC) v8.2 as a test management tool to load, update test case status upon test execution and for defect management.

Environment: Saleforce.com, Oracle, Toad, SQL Navigator, MS Visio, PRMS v8.4, Windows 7

Confidential, Athens, OH

Business Analyst

Responsibilities:

• Developed Functional Specification Document (FSD) and Business Requirements Document (BRD) for the Patient Management lifecycle in Salesforce
• Developed HIPAA Compliance Requirements.
• Developed Use Cases and create UML Activity and Sequence Diagrams to map processes and workflows.
• Developed Process Flow and Swim Lane diagrams in VISIO to document core business processes
• Customized Salesforce Standard Objects including Contacts, Leads, Reports, and Opportunities.
• Created Custom Field and Field Dependencies.
• Provided issue cause analysis, issue identification, issue prioritization, and effective resolution toPRMSsystem
• Developed Validation Rules on Standard and Custom Objects to maintain data quality
• Developed PL-SQL and SQL Scripts to migrate data from third-party databases and load into PPMS.
• Developed Informatica based mapping to load data into Staging Tables
• Developed DupeBlocker Rules to eliminate duplicate data from PPMS
• Managed entire lifecycle of Change Requests.
• Responsibility included requirement gathering, design, development, and testing of the applicationPRMS(revitalization of the Core ERP system
• Developed Custom Salesforce Reports using the Report Builder
• Prioritized requirement deliverables documented in BRD to meet the project milestones
• Built Traceability Matrix to and work with QA team to ensure functional testing is complete
• Reviewed Test Cases and Test Scenarios and coordinate User Acceptance Testing (UAT)
• Prepared User Manual

Environment: Saleforce.com, Oracle, Informatica, Toad, SQL Navigator, XML, MS Visio, PRMS, Windows 7

Confidential, Louisville, KY

Business Analyst

Responsibilities:

• Elicited demands from the stakeholders and analyzed them for consistency, flexibility, and completeness.
• Conducted JAD sessions with Subject Matter Experts to obtain domain level information.
• Presented and conducted functional requirement reviews and walkthroughs with the designers, developers, and stakeholders.
• Helped to communicate business priorities to the organization to effect business solutions
• Created and maintained BRD to assist PM close basis while managing multiple projects
• Converted Business Requirements to the Functional Specification
• Identified Use Cases from Business Requirements and created UML diagrams like use case diagram and activity diagram using MS-Visio for various stakeholders.
• Used Query Analyzer, Execution Plan to optimize SQL Queries.
• Involved with the quality assurance team to develop and design test plan and test cases.
• Managed change request and analyzed the impact of change request on the application in regards to Project Plan, Project Scope, and Project Schedule.

Environment: Rational Unified Process (RUP), UML, SQL, Rational Test Manager, Rational Clear Quest, Windows, MS Office, HTML, Windows